Trial Outcomes & Findings for Polyethylene Wear Study on the Triathlon Total Knee Prosthesis (NCT NCT02525588)

Last Updated: 2024-02-22

Results Overview

RSA is a highly accurate technique for the assessment of three-dimensional migration and micro motion of a joint replacement prosthesis relative to the bone it is attached to. Because of the high accuracy, RSA can also be used to measure wear in knee replacements and is used in this study for the assessment of the wear of the two polyethylene inlay types N2Vac polyethylene and X3 polyethylene.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

1, 2 and 5 years follow-up

Results posted on

2024-02-22

Participant Flow

Four patients were included into the study but not assigned to a group as prior to surgery two patients withdraw, one surgery was cancelled due to urinary tract infection and one patient met exclusion criteria BMI\>40

Participant milestones

Participant milestones
Measure	N2Vac Polyethylene Inlay Conventional UHMWPE inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.	X3 Highly Cross-linked Polyethylene X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.
Overall Study STARTED	48	48
Overall Study COMPLETED	42	45
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	N2Vac Polyethylene Inlay Conventional UHMWPE inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.	X3 Highly Cross-linked Polyethylene X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.
Overall Study Death	3	1
Overall Study Lost to Follow-up	2	0
Overall Study Withdrawal by Subject	1	1
Overall Study Adverse Event	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	N2Vac Polyethylene Inlay n=48 Participants Conventional UHMWPE inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.	X3 Highly Cross-linked Polyethylene n=48 Participants X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.	Total n=96 Participants Total of all reporting groups
Age, Continuous	64.42 years STANDARD_DEVIATION 10.24 • n=48 Participants	64.31 years STANDARD_DEVIATION 10.22 • n=48 Participants	64.36 years STANDARD_DEVIATION 10.23 • n=96 Participants
Sex: Female, Male Female	31 Participants n=48 Participants	32 Participants n=48 Participants	63 Participants n=96 Participants
Sex: Female, Male Male	17 Participants n=48 Participants	16 Participants n=48 Participants	33 Participants n=96 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Netherlands	48 participants n=48 Participants	48 participants n=48 Participants	96 participants n=96 Participants
BMI	29.32 kg/m^2 STANDARD_DEVIATION 4.18 • n=48 Participants	29.61 kg/m^2 STANDARD_DEVIATION 3.63 • n=48 Participants	29.46 kg/m^2 STANDARD_DEVIATION 3.90 • n=96 Participants
Indication Osteoarthritis	47 Participants n=48 Participants	47 Participants n=48 Participants	94 Participants n=96 Participants
Indication Post Traumatic Arthritis	1 Participants n=48 Participants	1 Participants n=48 Participants	2 Participants n=96 Participants
Smoker Non-Smoker	20 Participants n=48 Participants	20 Participants n=48 Participants	40 Participants n=96 Participants
Smoker Current Cigarette Smoke	4 Participants n=48 Participants	6 Participants n=48 Participants	10 Participants n=96 Participants
Smoker Ex Smoker	24 Participants n=48 Participants	22 Participants n=48 Participants	46 Participants n=96 Participants

PRIMARY outcome

Timeframe: 1, 2 and 5 years follow-up

Population: Negative wear values represent a decrease in liner thickness (= wear).

Outcome measures

Outcome measures
Measure	N2Vac Polyethylene Inlay n=45 Participants Conventional UHMWPE inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.	X3 Highly Cross-linked Polyethylene n=47 Participants X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.
Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). 1 year medial wear	-0.08 mm Standard Deviation 0.35	-0.03 mm Standard Deviation 0.48
Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). 1 year lateral wear	0.22 mm Standard Deviation 0.29	0.22 mm Standard Deviation 0.35
Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). 1 year total wear	-0.03 mm Standard Deviation 0.20	-0.00 mm Standard Deviation 0.26
Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). 2 years medial wear	-0.14 mm Standard Deviation 0.36	-0.11 mm Standard Deviation 0.47
Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). 2 years lateral wear	0.25 mm Standard Deviation 0.45	0.33 mm Standard Deviation 0.41
Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). 2 years total wear	-0.06 mm Standard Deviation 0.24	-0.04 mm Standard Deviation 0.16
Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). 5 years medial wear	-0.23 mm Standard Deviation 0.49	-0.16 mm Standard Deviation 0.47
Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). 5 years lateral wear	0.14 mm Standard Deviation 0.46	0.29 mm Standard Deviation 0.47
Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). 5 years total wear	-0.23 mm Standard Deviation 0.25	-0.08 mm Standard Deviation 0.17

SECONDARY outcome

Timeframe: 3 and 6 months,1, 2 and 5 years follow-up

Population: The migration of the prosthesis components was calculated with a minimum of four RSA bone markers. In some cases only 3 RSA bone markers was used to calculate the migration, leading to inaccurate orientation matching of the bone markers. These patients are not included in the results describing the two different liner groups.

RSA is a highly accurate technique for the assessment of three-dimensional migration and micro motion of a joint replacement prosthesis relative to the bone it is attached to. This study evaluates the prosthetic migration results with focus of the two years results of the Triathlon CS Peri-Apatite coated tibial and femoral components.

Outcome measures

Outcome measures
Measure	N2Vac Polyethylene Inlay n=46 Participants Conventional UHMWPE inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.	X3 Highly Cross-linked Polyethylene n=47 Participants X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.
Assessment of Prosthetic Migration Results After Two Years by RSA. Tibia migration 3 months	0.798 mm Standard Deviation 0.685	0.809 mm Standard Deviation 0.616
Assessment of Prosthetic Migration Results After Two Years by RSA. Tibia migration 6 months	0.873 mm Standard Deviation 0.771	0.903 mm Standard Deviation 0.677
Assessment of Prosthetic Migration Results After Two Years by RSA. Tibia migration 1 year	0.975 mm Standard Deviation 0.855	0.924 mm Standard Deviation 0.662
Assessment of Prosthetic Migration Results After Two Years by RSA. Tibia migration 2 years	1.043 mm Standard Deviation 0.930	0.956 mm Standard Deviation 0.681
Assessment of Prosthetic Migration Results After Two Years by RSA. Tibia migration 5 years	1.039 mm Standard Deviation 0.759	1.018 mm Standard Deviation 0.673
Assessment of Prosthetic Migration Results After Two Years by RSA. Femur migration 3 months	0.723 mm Standard Deviation 0.406	0.925 mm Standard Deviation 0.516
Assessment of Prosthetic Migration Results After Two Years by RSA. Femur migration 6 months	0.894 mm Standard Deviation 0.464	0.962 mm Standard Deviation 0.613
Assessment of Prosthetic Migration Results After Two Years by RSA. Femur migration 1 year	0.912 mm Standard Deviation 0.560	1.023 mm Standard Deviation 0.741
Assessment of Prosthetic Migration Results After Two Years by RSA. Femur migration 2 years	0.930 mm Standard Deviation 0.532	1.074 mm Standard Deviation 0.744
Assessment of Prosthetic Migration Results After Two Years by RSA. Femur migration 5 years	1.078 mm Standard Deviation 0.565	1.251 mm Standard Deviation 0.810

SECONDARY outcome

Timeframe: Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years

Population: Participants with available data. Overall number of participants and units analyzed is based upon the preoperative population.

The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.

Outcome measures

Outcome measures
Measure	N2Vac Polyethylene Inlay n=48 Participants Conventional UHMWPE inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.	X3 Highly Cross-linked Polyethylene n=48 Participants X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) Pain motion score pre-operative	49.09 units on a scale Standard Deviation 11.84	50.05 units on a scale Standard Deviation 15.72
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) Pain motion score 6 weeks	68.67 units on a scale Standard Deviation 15.45	66.06 units on a scale Standard Deviation 15.04
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) Pain motion score 3 months	77.45 units on a scale Standard Deviation 13.82	78.99 units on a scale Standard Deviation 15.57
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) Pain motion score 6 months	82.52 units on a scale Standard Deviation 10.83	83.17 units on a scale Standard Deviation 13.95
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) Pain motion score 1 year	84.36 units on a scale Standard Deviation 10.26	87.49 units on a scale Standard Deviation 9.42
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) Pain motion score 2 years	82.10 units on a scale Standard Deviation 12.48	83.53 units on a scale Standard Deviation 14.66
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) Pain motion score 5 years	82.68 units on a scale Standard Deviation 10.11	82.69 units on a scale Standard Deviation 9.89
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) Function score pre-op	62.29 units on a scale Standard Deviation 15.94	65.10 units on a scale Standard Deviation 14.09
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) Function score 6 weeks	55.11 units on a scale Standard Deviation 12.53	51.81 units on a scale Standard Deviation 18.17
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) Function score 3 months	74.35 units on a scale Standard Deviation 12.10	71.67 units on a scale Standard Deviation 21.00
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) Function score 6 months	82.55 units on a scale Standard Deviation 13.44	82.23 units on a scale Standard Deviation 13.20
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) Function score 1 year	87.39 units on a scale Standard Deviation 14.21	86.98 units on a scale Standard Deviation 12.82
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) Function score 2 years	87.39 units on a scale Standard Deviation 13.54	83.44 units on a scale Standard Deviation 16.66
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) Function score 5 years	88.05 units on a scale Standard Deviation 12.34	81.33 units on a scale Standard Deviation 18.93

SECONDARY outcome

Timeframe: Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years

Population: Participants with available data. Overall number of participants and units analyzed is based upon the preoperative population.

The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.

Outcome measures

Outcome measures
Measure	N2Vac Polyethylene Inlay n=48 Participants Conventional UHMWPE inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.	X3 Highly Cross-linked Polyethylene n=48 Participants X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Physical role functioning pre-operative	47.40 units on a scale Standard Deviation 23.24	44.81 units on a scale Standard Deviation 21.20
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Physical role functioning 6 weeks	30.45 units on a scale Standard Deviation 18.12	26.99 units on a scale Standard Deviation 18.73
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Physical role functioning 3 months	48.91 units on a scale Standard Deviation 23.90	47.14 units on a scale Standard Deviation 22.64
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Physical role functioning 6 months	61.04 units on a scale Standard Deviation 25.92	67.84 units on a scale Standard Deviation 22.86
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Physical role functioning 1 year	71.06 units on a scale Standard Deviation 23.18	69.28 units on a scale Standard Deviation 24.89
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Physical role functioning 2 years	68.75 units on a scale Standard Deviation 26.68	67.80 units on a scale Standard Deviation 24.13
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Physical role functioning 5 years	69.49 units on a scale Standard Deviation 25.41	66.25 units on a scale Standard Deviation 22.77
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Body pain pre-operative	41.25 units on a scale Standard Deviation 16.06	39.33 units on a scale Standard Deviation 16.61
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Body pain 6 weeks	44.79 units on a scale Standard Deviation 21.13	42.40 units on a scale Standard Deviation 17.46
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Body pain 3 months	58.09 units on a scale Standard Deviation 20.14	60.13 units on a scale Standard Deviation 21.20
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Body pain 6 months	68.23 units on a scale Standard Deviation 21.12	70.15 units on a scale Standard Deviation 21.46
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Body pain 1 year	72.33 units on a scale Standard Deviation 22.50	70.65 units on a scale Standard Deviation 23.20
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Body pain 2 years	70.61 units on a scale Standard Deviation 23.95	72.93 units on a scale Standard Deviation 23.17
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Body pain 5 years	76.14 units on a scale Standard Deviation 24.43	69.14 units on a scale Standard Deviation 24.35
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Vitality pre-operative	60.68 units on a scale Standard Deviation 16.24	61.72 units on a scale Standard Deviation 18.34
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Vitality 6 weeks	59.18 units on a scale Standard Deviation 16.70	58.59 units on a scale Standard Deviation 16.52
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Vitality 3 months	68.89 units on a scale Standard Deviation 17.17	62.89 units on a scale Standard Deviation 17.56
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Vitality 6 months	70.74 units on a scale Standard Deviation 17.59	68.23 units on a scale Standard Deviation 17.25
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Vitality 1 year	71.33 units on a scale Standard Deviation 16.57	68.62 units on a scale Standard Deviation 19.78
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Vitality 2 years	71.39 units on a scale Standard Deviation 17.15	68.21 units on a scale Standard Deviation 18.33
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Vitality 5 years	70.24 units on a scale Standard Deviation 15.89	69.31 units on a scale Standard Deviation 18.63
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Social role functioning pre-operative	73.18 units on a scale Standard Deviation 22.53	68.23 units on a scale Standard Deviation 23.10
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Social role functioning 6 weeks	61.70 units on a scale Standard Deviation 23.97	56.25 units on a scale Standard Deviation 26.02
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Social role functioning 3 months	79.89 units on a scale Standard Deviation 21.88	74.22 units on a scale Standard Deviation 24.79
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Social role functioning 6 months	87.50 units on a scale Standard Deviation 17.10	86.20 units on a scale Standard Deviation 21.54
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Social role functioning 1 year	86.41 units on a scale Standard Deviation 18.03	86.46 units on a scale Standard Deviation 21.01
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Social role functioning 2 years	89.17 units on a scale Standard Deviation 17.20	83.15 units on a scale Standard Deviation 23.20
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Social role functioning 5 years	88.99 units on a scale Standard Deviation 17.08	82.10 units on a scale Standard Deviation 23.60
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Emotional role functioning pre-operative	78.47 units on a scale Standard Deviation 22.36	70.14 units on a scale Standard Deviation 29.21
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Emotional role functioning 6 weeks	67.91 units on a scale Standard Deviation 29.07	64.18 units on a scale Standard Deviation 34.55
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Emotional role functioning 3 months	75.18 units on a scale Standard Deviation 23.34	74.65 units on a scale Standard Deviation 29.46
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Emotional role functioning 6 months	80.14 units on a scale Standard Deviation 24.10	80.90 units on a scale Standard Deviation 23.20
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Emotional role functioning 1 year	84.78 units on a scale Standard Deviation 19.99	79.69 units on a scale Standard Deviation 26.94
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Emotional role functioning 2 years	84.78 units on a scale Standard Deviation 22.81	75.18 units on a scale Standard Deviation 27.45
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Emotional role functioning 5 years	85.53 units on a scale Standard Deviation 21.32	80.74 units on a scale Standard Deviation 22.96
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Mental health pre-operative	76.98 units on a scale Standard Deviation 16.79	75.83 units on a scale Standard Deviation 19.32
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Mental health 6 weeks	75.00 units on a scale Standard Deviation 18.96	76.04 units on a scale Standard Deviation 18.68
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Mental health 3 months	80.98 units on a scale Standard Deviation 18.61	77.08 units on a scale Standard Deviation 21.21
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Mental health 6 months	82.98 units on a scale Standard Deviation 17.74	81.88 units on a scale Standard Deviation 18.02
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Mental health 1 year	84.89 units on a scale Standard Deviation 15.41	78.02 units on a scale Standard Deviation 21.35
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Mental health 2 years	84.22 units on a scale Standard Deviation 13.78	77.39 units on a scale Standard Deviation 19.97
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) Mental health 5 years	80.60 units on a scale Standard Deviation 18.23	80.00 units on a scale Standard Deviation 18.01
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) General health perceptions pre-op	70.50 units on a scale Standard Deviation 17.91	70.44 units on a scale Standard Deviation 17.89
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) General health perceptions 6 weeks	74.09 units on a scale Standard Deviation 15.51	71.13 units on a scale Standard Deviation 18.01
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) General health perceptions 3 months	75.70 units on a scale Standard Deviation 17.87	70.56 units on a scale Standard Deviation 19.07
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) General health perceptions 6 months	73.66 units on a scale Standard Deviation 17.71	70.23 units on a scale Standard Deviation 19.82
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) General health perceptions 1 year	72.83 units on a scale Standard Deviation 16.06	71.92 units on a scale Standard Deviation 20.59
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) General health perceptions 2 years	72.50 units on a scale Standard Deviation 16.85	69.63 units on a scale Standard Deviation 19.27
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) General health perceptions 5 years	69.90 units on a scale Standard Deviation 16.85	63.76 units on a scale Standard Deviation 21.29

SECONDARY outcome

Timeframe: Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years

Population: Participants with available data. Overall number of participants and units analyzed is based upon the preoperative population.

The EuroQol-5 Dimension (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; EQ-5D descriptive system and the visual analogue scale (VAS). The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health. With the EQ VAS the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).

Outcome measures

Outcome measures
Measure	N2Vac Polyethylene Inlay n=48 Participants Conventional UHMWPE inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.	X3 Highly Cross-linked Polyethylene n=48 Participants X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.
Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire EQ-5D descriptive pre-operative	0.52 units on a scale Standard Deviation 0.26	0.55 units on a scale Standard Deviation 0.25
Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire EQ-5D descriptive 6 weeks	0.65 units on a scale Standard Deviation 0.21	0.65 units on a scale Standard Deviation 0.21
Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire EQ-5D descriptive 3 months	0.75 units on a scale Standard Deviation 0.18	0.72 units on a scale Standard Deviation 0.21
Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire EQ-5D descriptive 6 months	0.78 units on a scale Standard Deviation 0.16	0.81 units on a scale Standard Deviation 0.22
Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire EQ-5D descriptive 1 year	0.81 units on a scale Standard Deviation 0.19	0.82 units on a scale Standard Deviation 0.24
Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire EQ-5D descriptive 2 years	0.85 units on a scale Standard Deviation 0.18	0.84 units on a scale Standard Deviation 0.18
Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire EQ-5D descriptive 5 years	0.81 units on a scale Standard Deviation 0.22	0.82 units on a scale Standard Deviation 0.23
Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire VAS pre-operative	68.27 units on a scale Standard Deviation 17.27	71.60 units on a scale Standard Deviation 14.97
Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire EQ-5D VAS 6 weeks	74.49 units on a scale Standard Deviation 12.48	71.46 units on a scale Standard Deviation 10.45
Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire EQ-5D VAS 3 months	76.74 units on a scale Standard Deviation 11.28	75.83 units on a scale Standard Deviation 11.50
Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire EQ-5D VAS 6 months	81.26 units on a scale Standard Deviation 11.19	78.63 units on a scale Standard Deviation 14.65
Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire EQ-5D VAS 1 year	81.98 units on a scale Standard Deviation 10.65	80.08 units on a scale Standard Deviation 14.37
Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire EQ-5D VAS 2 years	81.76 units on a scale Standard Deviation 11.85	79.14 units on a scale Standard Deviation 12.38
Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire EQ-5D VAS 5 years	79.38 units on a scale Standard Deviation 11.88	76.98 units on a scale Standard Deviation 12.22

SECONDARY outcome

Timeframe: Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years

Population: Participants with available data. Overall number of participants and units analyzed is based upon the preoperative population.

The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.

Outcome measures

Outcome measures
Measure	N2Vac Polyethylene Inlay n=48 Participants Conventional UHMWPE inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.	X3 Highly Cross-linked Polyethylene n=48 Participants X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.
Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire Activity level pre-operative	9.29 units on a scale Standard Deviation 2.69	8.98 units on a scale Standard Deviation 2.98
Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire Activity level 6 weeks	7.13 units on a scale Standard Deviation 0.64	7.06 units on a scale Standard Deviation 1.57
Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire Activity level 3 months	9.17 units on a scale Standard Deviation 2.39	8.73 units on a scale Standard Deviation 2.41
Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire Activity level 6 months	11.04 units on a scale Standard Deviation 2.67	11.00 units on a scale Standard Deviation 3.23
Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire Activity level 1 year	11.91 units on a scale Standard Deviation 2.41	11.10 units on a scale Standard Deviation 3.03
Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire Activity level 2 years	11.91 units on a scale Standard Deviation 2.98	11.04 units on a scale Standard Deviation 3.32
Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire Activity level 5 years	12.17 units on a scale Standard Deviation 3.34	10.87 units on a scale Standard Deviation 3.68

Adverse Events

N2Vac Polyethylene Inlay

Serious events: 22 serious events

Other events: 3 other events

Deaths: 3 deaths

X3 Highly Cross-linked Polyethylene

Serious events: 24 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	N2Vac Polyethylene Inlay n=48 participants at risk Conventional UHMWPE inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.	X3 Highly Cross-linked Polyethylene n=48 participants at risk X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.
Infections and infestations Urinary tract infection	6.2% 3/48 • Number of events 3 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	6.2% 3/48 • Number of events 3 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Vascular disorders Deep vein thrombisis	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	6.2% 3/48 • Number of events 3 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.

Additional Information

Britta von den Brincken, Clinical Study Manager

Stryker

Phone: +491638999202

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	N2Vac Polyethylene Inlay n=48 participants at risk Conventional UHMWPE inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.	X3 Highly Cross-linked Polyethylene n=48 participants at risk X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.
Infections and infestations Deep infection operatve site	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Surgical and medical procedures Delayed wound healing operative site	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Musculoskeletal and connective tissue disorders Flexion contracture operative site	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Injury, poisoning and procedural complications Hemarthrosis after use of anticoagulant	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Musculoskeletal and connective tissue disorders Arthrofibrosis operative site	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Musculoskeletal and connective tissue disorders Instability operative site	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Cardiac disorders Angina Pectoris	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Cardiac disorders Bradicardia	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Eye disorders Cataract	4.2% 2/48 • Number of events 2 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Gastrointestinal disorders Hernia diafragmatica	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Gastrointestinal disorders Gall bladder stones	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Gastrointestinal disorders Diarrhea for 30 days	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Immune system disorders Crohns Disease	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Immune system disorders Collitis	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Infections and infestations Infection of contralateral knee replacement	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Injury, poisoning and procedural complications Face surgery after fall accident	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Musculoskeletal and connective tissue disorders Carpal Tunnel Syndrome	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Musculoskeletal and connective tissue disorders Carpometacarpal joint 1 resection	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Musculoskeletal and connective tissue disorders Clavicle fracture	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Musculoskeletal and connective tissue disorders Ankle fracture	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Musculoskeletal and connective tissue disorders Shoulder tension rupture right	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Musculoskeletal and connective tissue disorders Lumbar vertebra stenosis	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Musculoskeletal and connective tissue disorders Tendovaginitis stenosis	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Toxic thyroid adenoma	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 2 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowel cancer	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urothelial cancer	4.2% 2/48 • Number of events 2 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Nervous system disorders Delirium	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Renal and urinary disorders Stress incontinence	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Renal and urinary disorders Hematuria	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.1% 1/48 • Number of events 2 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Vascular disorders Deep vein thrombosis	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Vascular disorders Vascular sclerosis	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Vascular disorders Inguinal artery obstruction	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Vascular disorders Arteria femoralis occlusion both sides	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Vascular disorders Vasovagal Collapse	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
Vascular disorders Stroke	0.00% 0/48 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.	2.1% 1/48 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.